The FDA granted breakthrough therapy designation to an oral, investigational, brain-penetrant and bioactive Bruton’s tyrosine kinase inhibitor for adults with non-relapsing secondary progressive MS.
According to a release from drug manufacturer Sanofi, the ruling was made after positive results were reported from the phase 3 HERCULES clinical trial, in which tolebrutinib delayed onset of 6-month confirmed disability progression by 31% compared placebo. In addition, treatment with tolebrutinib led to almost double the number of study participants who experienced confirmed disability